CA2764635C - Systemes d'administration de medicament topique pour une utilisation ophtalmique - Google Patents

Systemes d'administration de medicament topique pour une utilisation ophtalmique Download PDF

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Publication number
CA2764635C
CA2764635C CA2764635A CA2764635A CA2764635C CA 2764635 C CA2764635 C CA 2764635C CA 2764635 A CA2764635 A CA 2764635A CA 2764635 A CA2764635 A CA 2764635A CA 2764635 C CA2764635 C CA 2764635C
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CA
Canada
Prior art keywords
formulation
concentration
eye
dexamethasone
tpgs
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CA2764635A
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CA2764635A1 (fr
Inventor
Ashim K. Mitra
Poonam R. Velagaleti
Ulrich M. Grau
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Aurinia Pharmaceuticals Inc
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Aurinia Pharmaceuticals Inc
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Publication of CA2764635A1 publication Critical patent/CA2764635A1/fr
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/14—Quaternary ammonium compounds, e.g. edrophonium, choline
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/436—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents

Abstract

L'invention porte sur des systèmes d'administration de médicament topique pour une utilisation ophtalmique comprenant des formulations nano-micellaires mixtes de médicaments insolubles dans l'eau et sur des procédés de traitement de maladies affectant les segments oculaires postérieurs. Dans un certain mode de réalisation, une solution ophtalmique aqueuse comprend des nano-micelles dans un tampon physiologiquement acceptable, ayant un pH de 5,0 à 8,0, un corticostéroïde à une concentration d'environ 0,01 % p/v à environ 1,00 % p/v étant solubilisé par piégeage dans un noyau hydrophobe micellaire mixte avec une couronne composée de chaînes hydrophiles s'étendant à partir du noyau hydrophobe, les nano-micelles comprenant de la vitamine E TPGS à une concentration se situant dans la plage d'environ 3,0 % p/v à environ 5,0 % p/v stabilisée par de l'octoxynol-40 à une concentration se situant dans la plage d'environ 1,0 % p/v à environ 3,0 % p/v.
CA2764635A 2009-06-09 2010-05-05 Systemes d'administration de medicament topique pour une utilisation ophtalmique Active CA2764635C (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US18539609P 2009-06-09 2009-06-09
US61/185,396 2009-06-09
PCT/US2010/033779 WO2010144194A1 (fr) 2009-06-09 2010-05-05 Systèmes d'administration de médicament topique pour une utilisation ophtalmique

Publications (2)

Publication Number Publication Date
CA2764635A1 CA2764635A1 (fr) 2010-12-16
CA2764635C true CA2764635C (fr) 2018-05-22

Family

ID=43300918

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2764635A Active CA2764635C (fr) 2009-06-09 2010-05-05 Systemes d'administration de medicament topique pour une utilisation ophtalmique

Country Status (9)

Country Link
US (2) US9017725B2 (fr)
EP (1) EP2440185B1 (fr)
JP (1) JP2012529509A (fr)
CN (1) CN102458370A (fr)
AU (1) AU2010259184B2 (fr)
CA (1) CA2764635C (fr)
ES (1) ES2537385T3 (fr)
MX (1) MX338355B (fr)
WO (1) WO2010144194A1 (fr)

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CN102458370A (zh) 2012-05-16
MX2011012969A (es) 2012-02-01
US20100310642A1 (en) 2010-12-09
AU2010259184B2 (en) 2015-08-13
MX338355B (es) 2016-04-13
CA2764635A1 (fr) 2010-12-16
EP2440185B1 (fr) 2015-04-08
US9017725B2 (en) 2015-04-28
US20150202150A1 (en) 2015-07-23
AU2010259184A1 (en) 2011-12-15
WO2010144194A1 (fr) 2010-12-16
EP2440185A4 (fr) 2012-12-12
EP2440185A1 (fr) 2012-04-18
JP2012529509A (ja) 2012-11-22
ES2537385T3 (es) 2015-06-08

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